High Court National Institute Clinical Excellence Alzheimers drugs

As reported in our December 2006 update, a number of pharmaceutical companies and interested parties had sought judicial review of the decision of the NICE Board of Appeal to refuse to allow the prescription on the NHS of certain Alzheimer’s drugs for patients in the early stages of the disease. NICE argued that these drugs were not a cost effective use of the NHS’ resources. This was the first occasion that guidance from NICE has been subjected to legal challenge in the courts. The three drugs affected by NICE’s guidance were donepezil (Aricept, jointly marketed by Pfizer and Eisai), rivastigmine and galanthamine (Reminyl, marketed by Shire Pharmaceuticals).

On 10 August 2007, the High Court upheld NICE’s recommendation that these drugs should not be prescribed on the NHS for mild cases of Alzheimer’s disease (“AD”) but should be prescribed for moderately severe cases of AD only. It was not the role of the court to decide whether NICE had reached the correct decision in its guidance but merely whether the procedures and evidential evaluation carried out during the appeal process had been correctly applied. Mrs Justice Dobbs ruled that NICE’s decision had not been reached in an irrational or unfair manner.

The court did however hold that NICE’s guidance had failed to take into account disability discrimination law (in particular the discrimination that would arise out of rigid adherence to the use of a diagnostic assessment score known as MMSE) and should be amended accordingly. This amendment will not significantly affect the access to these drugs on the NHS however, save in the cases of ‘atypical’ patients such as those with a disability or poor command of English. In such cases, these factors must be taken into account when deciding upon the appropriate prescription.

The judgment has been met with extreme disappointment by a number of patient groups such as Age Concern who expressed their surprise that drugs costing as little as £2.50 per day would only be available for restricted prescription on the NHS. Paul Hooper, Eisai’s managing director, described the NICE’s guidance as “morally reprehensible” and confirmed that they will seek leave to appeal the court’s decision.

NICE’s chief executive, Andrew Dillon, claimed that the judgment strengthened NICE by endorsing its approach to evaluating drugs. He commented that “Alzheimer’s disease is a devastating illness, but the evidence indicates that these drugs are simply not effective for some patients. That is why we also issued advice last year on the broader support that should be provided for people with Alzheimer’s disease and those who care for them, creating core standards for the NHS and care homes that will make a real difference for patients and their families”.